CTRI/2022/02/040494Completed未知
A Prospective, Double Blind, Randomized, Parallel, Single-Center, Two-Arm, Placebo Controlled Clinical Study to Assess the Efficacy and Safety of KSM-66 Ashwagandha®capsule (300 mg) on Immune Function Enhancement and Quality of Life (QoL) in Healthy Subjects
Ixoreal Biomed0 sites60 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 60
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Adult males and females between 18 to 60 years of age. (Apparently healthy, as determined by medical history, physical examination)
- •2. Subjects with Immune Status Questionnaire of less than 6
- •3. Participants who agree to take investigational product (i.e., Till day 56)
- •4. Literate subject willing to give signed informed consent.
- •5. Willing to comply with study protocol requirements.
Exclusion Criteria
- •1. Participants who are not willing to take investigational product.
- •2. Any acute illness which may hamper the study participation as per PI discretion at the time of enrollment.
- •3. Individual participating in any other studies, including macro/micro/any other forms of dietary supplements/multivitamins or disease-specific oral nutrition supplements.
- •4. Patients with uncontrolled, unstable comorbidities.
- •5. Individuals with pre-existing respiratory conditions or diagnostic history with chronic lung disease, active malignancy, chronic kidney disease, chronic liver disease.
- •6. History of allergic reactions or anaphylaxis to investigational product components.
- •7. Participants with a history of or those currently on immunosuppressants.
- •8. Pregnant and lactating females.
- •9. Any other condition which the principal investigator thinks may jeopardize the safety of subjectsâ??patients with uncontrolled, unstable comorbidities.
- •10. Those with a history of clinically significant hypersensitivity reactions to immunomodulators. 11. Those with thyroid or pituitary disease
- •12. Those with immune system disease
- •13. Those with a history of systemic diseases such as multiple sclerosis, allergic skin disease and other autoimmune diseases
- •14. Those with a BMI of less than 18.5 kg/m2 at screening
- •15. Those who have received antipsychotic medication within 2 months before screening
- •16. Those with a alcoholism or history of substance abuse
- •17. Fertile women who do not accept the appropriate method of contraception (except for women who have undergone sterilization operation)
- •18. Participation in a clinical study during the preceding 90 days.
Investigators
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